Breakthrough Device Designation for AidaBREAST® - Early-Stage Invasive Breast Cancer Assay
Prelude Corporation (PreludeDx™), a leader in precision diagnostics for early-stage breast cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the AidaBREAST® test.
AidaBREAST provides individualized prognostic risk assessment and predicts the benefit of radiation therapy (RT) for women diagnosed with early-stage invasive breast cancer. The test integrates multi-omic data to generate a patient-specific assessment of 10-year locoregional recurrence risk and benefit from adjuvant radiation therapy, supporting more personalized treatment decisions following breast-conserving surgery.
Innovation Ventures congratulates Thea Tlsty, PhD, of the Department of Pathology and Director of the Center for Translational Research in the Molecular Genetics of Cancer at UCSF.